Location(s): Karnataka, India ⋅ Bengaluru, Karnataka, India
Experience Level(s): Mid Level ⋅ Senior
Field(s): Mechanical Engineering
Workplace Type: Hybrid
Pay: $140k/yr
Work Flexibility: Hybrid
What you will do-
Lead Design Assurance activities across multiple NPD programs and drive risk management (ISO 14971), usability engineering, and design controls
Provide guidance on complex technical and quality decisions and mentor junior engineers and influence cross-functional teams
Act as DAE Functional Lead (FL) for key programs
Ensure timely completion of Design reviews (DRs); Risk management deliverables (RMP, DFMEA, RT, etc.) and Verification & validation strategy
Proactively identify and mitigate program risks and partner with PD, Clinical, Regulatory, Quality, and Operations
Influence decisions without authority and drive alignment on design inputs, outputs, and usability strategy
Lead or contribute to Process improvement initiatives; improve DAE processes, templates, and ways of working and support audits and regulatory inspections
Drive usability strategy across programs and Ensure integration of user needs into product design
Lead/guide formative and summative evaluations
What you will need-
Required-
Bachelor’s/Master’s in Engineering (Mechanical preferred); relevant experience in medical device / regulated industry
Experience- 7 years - 10 years
Strong knowledge of Design Controls (21 CFR 820 / ISO 13485); Risk Management (ISO 14971) and Usability (IEC 62366)
Preferred-
Good communication and interpersonal skills.
Exposure to Engineering Drawing, GD&T, Manufacturing process of metals and plastics.